ClinicalTrials.gg
Not yet recruitingNCT07456761Updated Apr 2, 2026

Effect of Low-dose Pregabalin Retard (82.5 mg) Versus Standard-dose Pregabalin Retard (165 mg) on Postoperative Pain and Opioid Consumption After Elective Laparoscopic Abdominal Surgery

An interventional study of Pregabalin retard 82.5 mg and Pregabalin retard 165 mg in Laparoscopic Abdominal Surgeries, sponsored by South Egypt Cancer Institute. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-02.

Sponsored by South Egypt Cancer Institute · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The goal of this clinical trial is to detect whether pregabalin retard (82.5 mg or 165 mg) improves analgesia after elective laparoscopic abdominal surgery in adults. It will also evaluate the safety of both doses.

The main questions it aims to answer are:

Does the higher dose (165 mg) reduce the total amount of opioids needed in the first 24 hours after surgery compared to the lower dose (82.5 mg)? Do the pain scores differ between the two doses? Are there differences in side effects between the two doses?

Researchers will compare two different doses of pregabalin retard to determine which provides better pain control with fewer side effects.

Participants will:

Take one dose of pregabalin retard (82.5 mg or 165 mg) before surgery Receive standard anesthesia and multimodal pain treatment Have their pain levels and opioid use monitored for 24 hours after surgery Be assessed for side effects such as dizziness, nausea, or sedation

02

Conditions studied

  • Laparoscopic Abdominal Surgeries

Keywords

  • Pregabalin
  • Pain scores
  • Total opioid consumption
  • Laparoscopic abdominal surgery
03

In context

Lead sponsor

South Egypt Cancer Institute is the lead sponsor of 35 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18-75 years
  • I-III
  • Scheduled for elective laparoscopic abdominal surgery under general anesthesia (e.g. laparoscopic cholecystectomy, appendectomy, diagnostic/therapeutic laparoscopic procedures without expected conversion to open surgery)
  • Ability to understand the NRS pain scale and the study procedures
  • Written obtained

Exclusion criteria

Exclusion Criteria:

  • Known allergy or intolerance to pregabalin, gabapentinoids, or study medications
  • Chronic opioid use (daily use >30 mg oral morphine equivalent for >2 weeks preoperatively)
  • Regular use of gabapentin or pregabalin within 30 days
  • Severe renal impairment ( \< 30 mL/min/1.73 m²) or on dialysis
  • Severe hepatic impairment ( C)
  • Uncontrolled epilepsy or other major neurological disorder
  • Severe psychiatric disease, alcohol or substance abuse
  • Pregnancy or breastfeeding
  • Planned postoperative ICU admission for reasons other than routine overnight monitoring
  • Conversion to open abdominal surgery (these patients will be analyzed in sensitivity or excluded, predefined in analysis plan)
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    Group I (Low dose)

    Participants of this Arm will take pregabalin retard 82.5 mg orally with a sip of water, 1-2 hours before induction of anesthesia.

    Drug: Pregabalin retard 82.5 mg

  • Active comparator
    Group II (High dose)

    Participants of this Arm will take pregabalin retard 165 mg orally with a sip of water, 1-2 hours before induct

    Drug: Pregabalin retard 165 mg

Interventions

  • DrugPregabalin retard 82.5 mg

    Oral Administration 1-2 hours before elective laparoscopic abdominal surgery

  • DrugPregabalin retard 165 mg

    Oral Administration 1-2 hours before elective laparoscopic abdominal surgery

06

What researchers measure

Primary outcomes

  1. Cumulative opioid consumption (IV morphine equivalents) during the first 24 postoperative hours

    Time frame: 24 hours

Secondary outcomes

  1. Postoperative pain intensity

    Visual Analog Scale (0-10) at rest and during movement at predefined time points (2,4, 6,8 12,18 and 24h).

    Time frame: 2-24 hours postoperative

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Apr 2026; primary completion for Nov 2026, 7 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 2, 2026
First posted
Mar 6, 2026
StartEst.
Apr 2026
Primary completionEst.
Nov 2026
CompletionEst.
Dec 2026
Last update
Apr 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07456761
Lead sponsor
South Egypt Cancer Institute
Responsible party
Muhammad Gamal Thabet Ahmed (Lecturer of anesthesia, intensive care medicine and pain therapy, South Egypt Cancer Institute) — Principal investigator
First posted
Mar 6, 2026
Start date
Apr 2026 (estimated)
Primary completion
Nov 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Apr 2, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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